What it's for (Indications)
- Used in the treatment of severe recalcitrant nodular acne.
- Also indicated for other forms of nodular acne or long-term skin disease (acne vulgaris) where other treatments have been unsuccessful.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Use this medicine exactly as instructed by your doctor. Do not alter or skip the dose. Take by mouth with a glass of water, preferably with meals or with a glass of milk (note: specific formulations like ABSORICA/ABSORICA LD may be taken without regard to meals). Do not crush or chew the tablet; swallow it whole. Take this medicine at the same time every day to help you remember. If a dose is missed, skip that dose; do not take two doses at the same time. ABSORICA and ABSORICA LD are not substitutable due to different bioavailability and recommended dosages. Recommended dosage for ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses for 15 to 20 weeks. Recommended dosage for ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses for 15 to 20 weeks. Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of ABSORICA (1.6 mg/kg/day of ABSORICA LD) in divided doses. Once daily dosing is not recommended. |
Safety & Warnings
Common Side Effects
- Embryo-Fetal Toxicity, Psychiatric Disorders (including depression, anxiety, psychosis, suicidal ideation), Intracranial Hypertension (Pseudotumor Cerebri), Serious Skin Reactions (e.
- g.
- , Stevens-Johnson syndrome, toxic epidermal necrolysis), Pancreatitis, Lipid Abnormalities (e.
- g.
- , hypertriglyceridemia), Hearing Impairment, Hepatotoxicity, Inflammatory Bowel Disease (e.
- g.
- , ulcerative colitis, Crohn's disease), Musculoskeletal Abnormalities (e.
- g.
- , premature epiphyseal closure, bone pain, arthralgia), Ocular Abnormalities (e.
- g.
- , dry eyes, decreased night vision, cataracts), Hypersensitivity Reactions (e.
- g.
- , anaphylaxis, allergic vasculitis), Local irritation.
Serious Warnings
- Black Box Warning: WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY. ABSORICA/ABSORICA LD can cause life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of ABSORICA/ABSORICA LD even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected.
- Before using this medicine, inform your doctor about your complete medical history, especially mental illness, liver disease, kidney disease, eye disorders, increased fat in blood, diabetes, hearing impairment, bowel disease, and alcoholism.
- Perform pregnancy tests prior to prescribing, each month during therapy, at the end of therapy, and one month after discontinuation.
- Prior to prescribing, perform fasting lipid profile and liver function tests.
- Altered night vision and other visual disturbances may occur; avoid driving.
- Avoid alcohol consumption.
- Caution is advised for lactating females; consult your healthcare provider.
- Avoid contact with eyes, mouth, mucous membranes, abraded or sunburnt skin.
- Avoid UV light.
- Monitor for psychiatric disorders, intracranial hypertension, serious skin reactions, pancreatitis, lipid abnormalities, hearing impairment, hepatotoxicity, inflammatory bowel disease, musculoskeletal abnormalities, and hypersensitivity reactions.
How it Works (Mechanism of Action)
Isotretinoin is a retinoid that, when administered at recommended dosages, inhibits sebaceous gland function and keratinization. Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. This decrease in sebum secretion is temporary and related to the dose and duration of treatment, reflecting a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation. The exact mechanism of action in severe recalcitrant nodular acne is unknown.